Fexofenadine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Label updated
- 2017-12-01
- Retrieved
- 2026-09-07
- Active ingredients
- FEXOFENADINE HYDROCHLORIDE
Active ingredient (in each tablet)
Fexofenadine hydrochloride USP, 60 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
-
• runny nose -
• sneezing -
• itchy, watery eyes -
• itching of the nose or throat
Warnings
Do not use
if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you have
kidney disease. Your doctor should determine if you need a different dose.
When using this product
-
• do not take more than directed -
• do not take at the same time as aluminum or magnesium antacids -
• do not take with fruit juices (see Directions)
Stop use and ask a doctor if
an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
|
adults and children 12 years of age and over |
take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours |
|
children under 12 years of age |
do not use |
|
adults 65 years of age and older |
ask a doctor |
|
consumers with kidney disease |
ask a doctor |
Other information
-
• Tamper Evident: do not use if foil seal under cap is missing, open or broken -
• store between 20° to 25°C (68° to 77°F) -
• protect from excessive moisture
Inactive ingredients
Butylated hydroxyanisole, crospovidone, FD&C Blue No. 1 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, titanium dioxide and triacetin.
Questions or comments?
Call 1-877-446-3679 (1-877-4-INFO-RX)
Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Marketed/ Packaged by: GSMS, Inc., Camarillo, CA 93012 USA
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 180 mg |
| 30 | 43353-760-30 |
| 60 | 43353-760-53 |
| 90 | XXXXX-XXX-60 |
| 120 | XXXXX-XXX-70 |
| 180 | XXXXX-XXX-80 |
| 240 | XXXXX-XXX-90 |
| 270 | XXXXX-XXX-92 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
[Image in the official label — see DailyMed source]
Cookeville, TN 38506
20171201JH
PRINCIPAL DISPLAY PANEL - 180mg
NDC 43353-760 - Fexofenadine HCl 180mg - Rx Only
[Image in the official label — see DailyMed source]
DailyMed Set ID: d0a79081-71e0-407d-876b-f4393fd4d1e5 · Version 1
NDC: 43353-760